Identity
- Trade Name
- DDU-100 Lifeline AED with RX activation form FDA UDI
- Generic Name
- Non-rechargeable public semi-automated external defibrillator FDA UDI
- Device Name
- DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 7 year battery pack with 9V Lithium battery (DCF-210), prescription activation form FDA UDI
- Model / Reference
- DCF-A110RX-EN FDA UDI
- Description
- DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 7 year battery pack with 9V Lithium battery (DCF-210), prescription activation form FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815098020744 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Non-rechargeable public semi-automated external defibrillator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.5310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-rechargeable public semi-automated external defibrillator
DDU-100 Lifeline AED with RX activation form by Defibtech, L.l.c. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Defibtech, L.l.c.
Sources (1)
- FDA UDI e6c34096-354f-4d2c-a259-e47e729e70dc 33 fields · synced May 30, 2026